CompletedNot Applicable

An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers

Sweden433 participantsStarted 2022-09-01

Plain-language summary

A double blind, non randomized, multicenter investigation

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Given their written consent to participate in the study
. Male or female between ≥18 years and ≤ 64 years with a reduced mobility, where the hospitalization may involve a risk that the person may become less active or Male or female ≥65 years

Exclusion criteria

. Existing pressure ulcer or damage to the skin around the sacrum where the PU sensor plate and pillow are to be placed
. Fever ≥38 ºC, within 30 minutes before the examination with PU sensor
. Difficulty lying still in supine position during the examination with PU sensor, which takes 5 to 10 minutes
. Known allergy or sensitivity to any of the materials in PU sensor that gets in contact with the skin on the sacrum
. Body weight ≥200 kg
. Previous participation in the study
. Mental inability, or language difficulties that results in difficulty to understand the meaning of participation in the study and / or signing the study consent,
. Pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of pressure ulcers developed between visit 1 and 2

Timeframe: Up to 4 weeks

Trial details

NCT IDNCT05458050

SponsorPU sensor AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Pressure Ulcer trials